Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments | Federal Regulations · Congress.wiki

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FDA

FDA-2026-N-0232

Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments

Documents

Comments

Description

Open

Comment Period OpensFeb 6, 2026

Comment Period ClosesApr 8, 2026

Type	Title	Posted	Comments	Status
Supporting Material	Reference 1 - Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff	Feb 6, 2026	--

Total Comments

CDRH

FRDTS # 2025-487

Medical Devices

Exemptions from Premarket Notification:

Class II Devices; Request for Comments

Open